Back to resultsDevelopment of Patient Tailored Guideline of Physical Activity for Lung Cancer
Primary Purpose
Lung Cancer
Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
comprehensive intervention
Sponsored by
About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring physical activity, cardiopulmonary function, quality of life, Perioperative management, comprehensive intervention, health behavior model
Eligibility Criteria
Inclusion Criteria:
- lung cancer patients before surgery
Exclusion Criteria:
- Eastern Cooperative Oncology Group Performance Status <1
- Neoadjuvant therapy
- Multiple cancer
- Recurrent lung cancer.
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
observation
comprehensive intervention
Arm Description
No Intervention
preoperative: exercise counseling postoperative : symptoms counseling and pulmonary rehabilitation
Outcomes
Primary Outcome Measures
Changes of cardiopulmonary function
six minute walk test
Secondary Outcome Measures
complication
Pneumonia
Changes of pulmonary function
forced expiratory volume at one second, forced vital capacity
Changes of physical activity
wearable device
Changes of physical fitness
muscle strengths
Changes of quality of life
quality of life questionnaire
Changes of Fatigue
Fatigue questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03215537
Brief Title
Development of Patient Tailored Guideline of Physical Activity for Lung Cancer
Official Title
Development of Patient Tailored Guideline of Physical Activity for Lung Cancer Survivor After Surgery; to Improve the Symptoms, Complications and Quality of Life
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 2, 2016 (Actual)
Primary Completion Date
November 16, 2020 (Actual)
Study Completion Date
December 2, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Samsung Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following
Detailed Description
This study aims to propose a perioperative comprehensive intervention based on health behavior model to improve cardiopulmonary function and quality of life among lung cancer patients following:
understanding multi-dimensional factors affecting cardiopulmonary function and quality of life
development of multidisciplinary comprehensive intervention
evaluation the effects of comprehensive intervention using cluster design
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
physical activity, cardiopulmonary function, quality of life, Perioperative management, comprehensive intervention, health behavior model
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
176 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
observation
Arm Type
No Intervention
Arm Description
No Intervention
Arm Title
comprehensive intervention
Arm Type
Active Comparator
Arm Description
preoperative: exercise counseling postoperative : symptoms counseling and pulmonary rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
comprehensive intervention
Intervention Description
preoperative and postoperative exercise program
Primary Outcome Measure Information:
Title
Changes of cardiopulmonary function
Description
six minute walk test
Time Frame
Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Secondary Outcome Measure Information:
Title
complication
Description
Pneumonia
Time Frame
1 month after surgery, 6 months after surgery, 1year after surgery
Title
Changes of pulmonary function
Description
forced expiratory volume at one second, forced vital capacity
Time Frame
Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Title
Changes of physical activity
Description
wearable device
Time Frame
Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Title
Changes of physical fitness
Description
muscle strengths
Time Frame
Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Title
Changes of quality of life
Description
quality of life questionnaire
Time Frame
Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
Title
Changes of Fatigue
Description
Fatigue questionnaire
Time Frame
Baseline, 1 month after surgery, 6 months after surgery, 1year after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
lung cancer patients before surgery
Exclusion Criteria:
Eastern Cooperative Oncology Group Performance Status <1
Neoadjuvant therapy
Multiple cancer
Recurrent lung cancer.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jae Ill Zo
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Development of Patient Tailored Guideline of Physical Activity for Lung Cancer
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